Parvovirus B19 Infection in Pregnancy: Clinical Manifestations and Fetus/Newborn Outcome (ParvoPre)

January 7, 2026 updated by: Daniele Lilleri, Fondazione IRCCS Policlinico San Matteo di Pavia
The goal of this observational study is to define the rate of intrauterine parvovirus B19 infection and fetal/newborn complications after parvovirus B19 infection of pregnant women. Secondary objectives are risk factors, pregnancy outcomes, long-term sequelae and efficacy of the management interventions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Not yet recruiting
        • Asst Degli Spedali Civili Di Brescia
        • Contact:
      • Milan, Italy, 20122
      • Milan, Italy, 20157
      • Monza, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

Inclusion Criteria:

  • Pregnant women >18 years with parvovirus B19 infection and their neonates.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of fetuses/newborns with intrauterine B19V infection.
Time Frame: From diagnosis of parvovirus B19 infection in pregnancy to 24/48 hours of life of the newborn.
From diagnosis of parvovirus B19 infection in pregnancy to 24/48 hours of life of the newborn.
Percentage of fetuses/newborns with complications due to B19V intrauterine infection.
Time Frame: From diagnosis of parvovirus B19 infection in pregnancy to 24/48 hours of life of the newborn.
From diagnosis of parvovirus B19 infection in pregnancy to 24/48 hours of life of the newborn.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women with symptomatic B19V infection.
Time Frame: At diagnosis of parvovirus B19 infection in pregnancy
At diagnosis of parvovirus B19 infection in pregnancy
Percentage of fetuses with B19V disease.
Time Frame: From diagnosis of parvovirus B19 infection in pregnancy to delivery.
The following findings will be considered: anemia, hydrops, ascites, pericardial effusion, pleural effusion, subcutaneus oedema, cardiomegaly, placental thickening, cerebral abnormalities, growth retardation.
From diagnosis of parvovirus B19 infection in pregnancy to delivery.
Percentage of fetuses receiving intrauterine transfusion.
Time Frame: From diagnosis of parvovirus B19 infection in pregnancy to delivery.
From diagnosis of parvovirus B19 infection in pregnancy to delivery.
Percentage of newborns with B19V disease.
Time Frame: From diagnosis of parvovirus B19 infection in pregnancy to 20/30 days of life of the newborn.
The following signs/symptoms will be considered: anemia, paleness, petechiae, purpura, icterus, hepato-splenomegaly, ascites, hydrops, pleural effusion, pericardial effusion, neurologic abnormalities.
From diagnosis of parvovirus B19 infection in pregnancy to 20/30 days of life of the newborn.
Percentage of infants with neurologic abnormalities.
Time Frame: From birth to 2 years of life.
From birth to 2 years of life.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ASST Fatebenefratelli Sacco
Fondazione IRCCS San Gerardo dei Tintori
Asst Degli Spedali Civili Di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ParvoPre

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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